HealthynutralysNCT02128516
NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass
A study testing oral powder in sachet in people with Healthy, run by Nicolas Babault at 1 site in France.
Trial summary
this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an intermediate profile, rich in leucines and other essential amino acids, can significantly enhance muscle mass gain during strength training. This study will compare the efficacy of NUTRALYS® to a reference product. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- oral powder in sachet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects from 18 to 35 years of age:
- engaged in moderate or occasional sports activity;
- having given their written informed consent;
- in gainful employment or a student;
- in possession of a medical certificate of fitness for sports
Who cannot join
- Subject already engaged in regular sports or training increasing muscle strength or volume in the upper limbs and particularly the biceps brachial;
- Subject engaged or having engaged in the last 6 months in weight training more than once a week;
- Subject having had a muscle injury in the 3 months prior to the study;
- Asthmatic subject liable to be administered corticosteroids;
- Subject taking part in another trial;
- Subject with a known hypersensitivity to whey or pea proteins;
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- Subject deprived of their freedom for administrative, medical or legal reasons or not in possession of the legal or ethical capacity to enter into a contract due to cognitive function impairment;
- Subject liable not to comply with the constraints required by the protocol;
- Subject not covered by health insurance;
- Subject having taken in the previous month or currently taking: medication, a dietary supplement, sports drink, food for particular nutritional uses or functional foods, of any kind, liable or described as liable to increase physical performance and notably to increase muscle mass;
- Subject taking anabolic protein or corticosteroid treatment;
- Subject on a high-protein diet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled, Randomized, Parallel, Double-blind Study of the Effect of NUTRALYS® Pea Protein Supplementation Versus Whey Protein and Placebo on the Muscle Mass and Strength of Volunteers Engaged in Training
this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an intermediate profile, rich in leucines and other essential amino acids, can significantly enhance muscle mass gain during strength training. This study will compare the efficacy of NUTRALYS® to a reference product. If the results of the study demonstrate a significant improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be considered as an alternative to sports nutrition products, to which many people are intolerant.
- Conditions
- Healthy
- Being tested
- oral powder in sachet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral powder in sachetOther
Also called Sachet for oral use composed of proteins (pea or whey) and/or other components (fat-reduced cocoa, flavouring, aspartame, salt, silica dioxide)
| Study group | Role | What they receive |
|---|---|---|
| whey protein | Active comparator | whey protein Receives: Other: oral powder in sachet |
| placebo | Placebo comparator | placebo Receives: Other: oral powder in sachet |
| pea protein | Experimental | pea protein Receives: Other: oral powder in sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biceps brachial thickness measured using ultrasonography
biceps muscle thickness measured in millimeter using images from ultrasonography
Measured: 12 weeks after first ingestion
Secondary outcomes (5)
Elbow flexor strength
Elbow flexors muscle strength measured in Newton meter using a Biodex isokinetic dynamometer in concentric, eccentric and isometric conditions.
Measured: 12 weeks after first ingestion
Biceps circumference
the circumference of the arm in three sites (proximal, middle and distal) using a tape (centimeter)
Measured: 12 weeks after first ingestion
body weight
Body mass in kg on a scale
Measured: 12 weeks after first ingestion
tolerance
Tolerance measured by quantifying adverse events
Measured: 12 weeks after first ingestion
muscle force
maximal weight lifted during an arm curl exercise (kg)
Measured: 12 weeks after first ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJan 2012
- Primary completionApr 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolas Babault
- Sponsor type
- University, hospital or other
- Collaborators
- Roquette Freres
- Responsible party
- Sponsor-investigator, Nicolas Babault, University of Burgundy
- Investigators
- Francois A Allaert, MD, Principal investigator, CEN Nutriment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128516
- Sponsor's protocol ID
- CEN1118
- Acronym
- nutralys
- Status last verified
- Apr 2014
- First submitted
- 24 Apr 2014
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Babault N, Paizis C, Deley G, Guerin-Deremaux L, Saniez MH, Lefranc-Millot C, Allaert FA. Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, Placebo-controlled clinical trial vs. Whey protein. J Int Soc Sports Nutr. 2015 Jan 21;12(1):3. doi: 10.1186/s12970-014-0064-5. eCollection 2015.
PubMed 25628520
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Randomized, Parallel, Double-blind Study of the Effect of NUTRALYS® Pea Protein Supplementation Versus Whey Protein and Placebo on the Muscle Mass and Strength of Volunteers Engaged in Training
- ClinicalTrials.gov ID
- NCT02128516
- Acronym / sponsor ID
- nutralys / CEN1118
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nicolas BabaultUniversity, hospital or other
- Collaborators
- Roquette Freres
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an intermediate profile, rich in leucines and other essential amino acids, can significantly enhance muscle mass gain during strength training. This study will compare the efficacy of NUTRALYS® to a reference product. If the results of the study demonstrate a significant improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be considered as an alternative to sports nutrition products, to which many people are intolerant.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| whey protein | Active comparator | Other: oral powder in sachetwhey protein |
| placebo | Placebo comparator | Other: oral powder in sachetplacebo |
| pea protein | Experimental | Other: oral powder in sachetpea protein |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects from 18 to 35 years of age:
- engaged in moderate or occasional sports activity;
- having given their written informed consent;
- in gainful employment or a student;
- in possession of a medical certificate of fitness for sports
Key exclusion criteria (12 listed)
- Subject already engaged in regular sports or training increasing muscle strength or volume in the upper limbs and particularly the biceps brachial;
- Subject engaged or having engaged in the last 6 months in weight training more than once a week;
- Subject having had a muscle injury in the 3 months prior to the study;
- Asthmatic subject liable to be administered corticosteroids;
- Subject taking part in another trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral powder in sachetAlso: Sachet for oral use composed of proteins (pea or whey) and/or other components (fat-reduced cocoa, flavouring, aspartame, salt, silica dioxide) | Other | pea protein, placebo, whey protein |
Primary outcome
Biceps brachial thickness measured using ultrasonography
Time frame: 12 weeks after first ingestion
biceps muscle thickness measured in millimeter using images from ultrasonography
5 secondary outcomes
Elbow flexor strength
Time frame: 12 weeks after first ingestion
Biceps circumference
Time frame: 12 weeks after first ingestion
body weight
Time frame: 12 weeks after first ingestion
tolerance
Time frame: 12 weeks after first ingestion
muscle force
Time frame: 12 weeks after first ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
- Derived from this study: PubMed 25628520Babault N, Paizis C, Deley G, Guerin-Deremaux L, Saniez MH, Lefranc-Millot C, Allaert FA. Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, Placebo-controlled clinical trial vs. Whey protein. J Int Soc Sports Nutr. 2015 Jan 21;12(1):3. doi: 10.1186/s12970-014-0064-5. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois A Allaert, MD principal investigator
CEN Nutriment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral powder in sachet in people with Healthy, run by Nicolas Babault at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biceps brachial thickness measured using ultrasonography (time frame: 12 weeks after first ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.